All applications submitted to NIH from January 10, 2005 and onward must be coded in the NIH IMPAC II system according to the definitions in the HHS regulations that have been clarified in the OHRP Guidance on Research Involving Coded Private Information or Biological Specimens. These include clarifications of: “Investigator,” Obtaining,” and “Coded.”

The goal of the OHRP Guidance is to:

provide guidance as to when research involving coded private information or biological specimens is or is not research involving human subjects, as defined under HHS regulations for the protection of human subjects (45 CFR part 46).

Briefly, research with coded human data or specimens does not involve human subjects if they were not collected specifically for the proposed study and the investigators cannot readily ascertain the identities of the donors because, for example, the key to the code was destroyed before the research begins; or there is a non-disclosure agreement between the provider and the investigator; or there are local IRB policies that prohibit release of the key to the code; or there are other legal requirements that prohibit release of the key to the code.

The Guidance goes beyond coded material as it provides definitions to key terms:

Obtains is to receive or access individually identifiable human data or specimens, even if already in the investigator's possession.

Investigator is anyone involved in conducting the research. Those engaged in human subjects research include individuals and repositories who provide coded human data or specimens and who collaborate on other activities related to conducting the research. Those who solely provide previously collected coded human data or specimens without a key to the code are not involved in human subjects research.

Coded means (1) identifying information (such as name or social security number) that would enable the investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain has been replaced with a number, letter, symbol, or combination thereof (i.e., the code); and (2) a key to decipher the code exists, enabling linkage of the identifying information to the private information or specimens.